In the medical field, flexible containers such as overpouches and dustcovers store, protect and transport medical components such as medical delivery systems for parenteral, pharmaceutical, flushes, nutrition, irrigating, respiratory therapy agents, dialysis, blood, blood products, renal, plasma derivatives, plasma expanders, blood substitutes, anti-coagulants, blood preservatives, and other therapeutic agents. As such, it is necessary for the overpouch container to be compatible with the medical component disposed therein. For example, the overpouch container requires appropriate optical transparency to enable the visual inspection of contaminants within the overpouch and/or the medical component, such as an IV solution bag. It is also necessary for the overpouch container to withstand the autoclaving or sterilization process without wrinkling the medical component, discoloring, and/or adhering to the medical component. Other desirable attributes for the overpouch container include easy access to the pouch's contents; abrasion, tear, puncture and flex-crack resistance; and a composition the allows heat sealability.
Conventional overpouch containers composed of high density polyethylene fail to provide all of the aforementioned desirable properties. For example, when high density polyethylene overpouches containing a medical component are autoclaved (i.e., exposed to steam at temperature of about 121° C. and elevated pressure), the overpouch tends to wrinkle the medical component disposed therein. Traditional polyvinyl chloride (PVC) is also an unfavorable material for overpouch films. PVC generates objectionable amounts of hydrogen chloride upon incineration. In addition, PVC materials typically contain plasticizers that may leach into drugs, biological fluids or tissues that come in contact with the PVC material.
A need exists for a safe, clean, drug compatible, and cost-effective composition that may be fabricated into an overpouch container having the aforementioned positive attributes. In particular, a need exists for an overpouch film material that does not wrinkle or deform a medical component disposed in the overpouch during the autoclave process.